The Lombardi Comprehensive Cancer Center (Lombardi) participates in a wide range of innovative, feasibility, or proof-of- principle trials originating from its research programs. Enrollment in these studies has remained stable during the last grant period. The conduct of these studies is supported by research nursing and data management provided by the Clinical Research Management Office (CRMO). Research nursing focuses solely on the eligibility, consenting, and management of patients on clinical trials all of which is increasingly difficult in today's medical and regulatory environment In addition to its participation in the scope of high-priority clinical trials, Lombardi has conducted a series of innovative phase I trials of cancer vaccines and targeted agents that have provided important information on the mechanisms and clinical efficacy of these agents. These trials are among an extensive portfolio of phase I studies. The interaction of basic science and clinical programs has resulted in the testing of a series of agents that have been developed at Lombardi. The strong emphasis in translational research and drug development is reflected in the accomplishment of Lombardi investigators who have developed and brought to trial targeted agents, growth factor inhibitors, and radiation sensitizing agents. Lombardi continues to play a major role in the treatment and prevention of breast cancer. Selected, high priority clinical trials are given cancer center funding to support their execution. Such funds may come from the CCSG or from institutional sources. Regular Drug Discovery and Developmental Therapeutics (3DT) Program meetings include the presentation of new clinical trial concepts to a multidisciplinary group that includes 3DT members and members of other CCSG programs. The group prioritizes the trials, and the 3DT Program Leaders propose CCSG support to the Lombardi Director, who then assigns funds with the counsel of the Associate Directors and the Senior Operational Leadership Team.